Evaluation Surrogate Endpoints (26 results)

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Condition: Hervorragend. Zustand: Hervorragend | Seiten: 334 | Sprache: Englisch | Produktart: Bücher | "Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process."--Publisher's description.…

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Taschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - Both humanitarian and commercial considerations have spurred intensive search for methods to reduce the time and cost required to develop new therapies. The identification and use of surrogate endpoints, i.e., measures that can replace or supplement other endpoints in evaluations of experimental treatments or other interventions, is a general strategy that has stimulated both enthusiasm and skepticism. Surrogate endpoints are useful when they can be measured earlier, more conveniently, or more frequently than the 'true' endpoints of primary interest. Regulatory agencies around the globe, particularly in the United States, Europe, and Japan, are introducing provisions and policies relating to the use of surrogate endpoints in registration studies. But how can one establish the adequacy of a surrogate What kind of evidence is needed, and what statistical methods portray that evidence most appropriately This book offers a balanced account on this controversial topic. The text presents major developments of the last couple of decades, together with a unified, meta-analytic framework within which surrogates can be evaluated from several angles. Methodological development is coupled with perspectives on various therapeutic areas. Academic views are juxtaposed with standpoints of scientists working in the biopharmaceutical industry as well as of colleagues from the regulatory authorities.Tomasz Burzykowski is Assistant Professor of Biostatistics at the Limburgs Universitair Centrum in Belgium. Dr. Burzykowski has published methodological work on the analysis of survey data, meta-analyses of clinical trials, and validation of surrogate endpoints. He is a co-author of numerous papers applying statistical methods to clinical data in different disease areas (cancer, cardiovascular diseases, dermatology, orthodontics).Geert Molenberghs is Professor of Biostatistics at the Limburgs Universitair Centrum in Belgium. Dr. Molenberghs published methodological work on surrogate markers in clinical trials, categorical data, longitudinal data analysis, and on the analysis of non-response in clinical and epidemiological studies. He serves as Joint Editor for Applied Statistics (2001-2004) and is President of the International Biometric Society (2004-2005). He was elected Fellow of the American Statistical Association and received the Guy Medal in Bronze from the Royal Statistical Society. Marc Buyse founded the International Drug Development Institute in 1991. He is Past President of the International Society for Clinical Biostatistics, Past President of the Quetelet Society, and Past Board Member of the Society for Clinical Trials. He is currently the Executive Director of IDDI (International Drug Development Institute) and Associate Professor of biostatistics at the Limburgs Universitair Centrum, Center for Statistics, Diepenbeek, Belgium. He has published extensively in the fields of biostatistics and oncology. His research interests include meta-analysis, surrogate endpoints, statistical detection of fraud, and the design and statistical analysis of clinical trials.From the reviews:'A strength of this book is its comprehensive and up-to-date presentation of issues pertinent to the evaluation of surrgoate endpoints.This book makes an important contribution to the clinical trials literature.' Journal of Biopharmaceutical Statistics, 2006'Many of the chapters deal with real-life data examples and studies involving surrogate outcomes, many written by authors who were directly involved in these studies.The editors have written nice background sections.until a more concise manuscript on this topic is written, this book will remain the most important resource for biostatisticians and researchers in this area.' Debajyoti Sinha for the Journal of the American Statistical Association, December 2006'This book is a reflection of the ongoing debate.…

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Taschenbuch. Condition: Neu. The Evaluation of Surrogate Endpoints | Tomasz Burzykowski (u. a.) | Taschenbuch | Statistics for Biology and Health | xxiv | Englisch | 2010 | Springer | EAN 9781441919069 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu. …

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Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Covers the latest research on a sensitive and controversial topic in a professional and well researched manner.Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not.Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide.Provides dual viewpoints: from scientists in the industry as well as regulatory authorities. 436 pp. Englisch.…

Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Covers the latest research on a sensitive and controversial topic in a rpofessional and well researched mannerProvides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools.…

Taschenbuch. Condition: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Both humanitarian and commercial considerations have spurred intensive search for methods to reduce the time and cost required to develop new therapies. The identification and use of surrogate endpoints, i.e., measures that can replace or supplement other endpoints in evaluations of experimental treatments or other interventions, is a general strategy that has stimulated both enthusiasm and skepticism.This book offers a balanced account on this controversial topic. The text presents major developments of the last couple of decades, together with a unified, meta-analytic framework within which surrogates can be evaluated from several angles. Methodological development is coupled with perspectives on various therapeutic areas. Academic views are juxtaposed with standpoints of scientists working in the biopharmaceutical industry as well as of colleagues from the regulatory authorities.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 436 pp. Englisch. …

Condition: New. Print on Demand pp. xxiv + 416.

Gebunden. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Covers the latest research on a sensitive and controversial topic in a rpofessional and well researched mannerProvides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools.…

Condition: New. PRINT ON DEMAND pp. xxiv + 416.